AFT Pharmaceuticals has now concluded a pivotal clinical study of 408 patients in the US and NZ. The study will form the basis of AFT’s first filing with the United States Food and Drug Administration for its flagship analgesic Maxigesic.
Ioana Stanescu, head of Drug Development at AFT Pharmaceuticals, says that the results from these trials have been very positive. “As expected, from a safety point of view the results are good. What is really noticeable though is the efficacy results. They are quite something. The R&D team is very happy, put it that way.”
Ms Stanescu says that the full results of the trials will be made available as soon as the regulatory approval process allows.
Reade more about the safety & efficacy trials for Maxigesic® here.